NCT00576602

Brief Summary

This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_4

Geographic Reach
6 countries

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

December 18, 2007

Last Update Submit

November 3, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Change in Hb concentration between baseline and efficacy evaluation period (EEP).

    Weeks 13-16

Secondary Outcomes (3)

  • Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions.

    Throughout study

  • SF36

    Weeks 16 and 48

  • AEs, laboratory parameters.

    Throughout study

Study Arms (2)

1

EXPERIMENTAL
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

2

ACTIVE COMPARATOR
Drug: Supportive treatment

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks

1
Supportive treatmentDRUG

As prescribed

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, \>=18 years of age;
  • kidney transplant \>=6 months and \<5 years prior to randomization;
  • anemia;
  • no ESA therapy during 3 months prior to randomization.

You may not qualify if:

  • requirement for hemodialysis or peritoneal dialysis within 3 months prior to randomization;
  • change in Hb concentration \>=1.5g/dL during screening period;
  • transfusion of red blood cells during 3 months prior to randomization;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding within 3 months prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

Edegem, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Amiens, France

Location

Unknown Facility

Caen, France

Location

Unknown Facility

Le Kremlin-Bicêtre, France

Location

Unknown Facility

Nice, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Toulouse, France

Location

Unknown Facility

Tours, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Frankfurt am Main, Germany

Location

Unknown Facility

Kaiserslautern, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Bari, Italy

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Santander, Spain

Location

Unknown Facility

Seville, Spain

Location

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activatorPalliative Care

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

December 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

FR(7)GB(1)BE(3)IT(1)ES(3)DE(5)